Cleared Traditional

S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE

K132462 · Hitachi Chemical Diagnostics, Inc. · Chemistry
Oct 2013
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K132462 is an FDA 510(k) clearance for the S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE, a Urease, Photometric, Urea Nitrogen (Class II — Special Controls, product code CDN), submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 28, 2013, 82 days after receiving the submission on August 7, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K132462 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2013
Decision Date October 28, 2013
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDN — Urease, Photometric, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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